Sistema de Autorregulación
The Directives approved concerning the promotion of medicines for human use (92/28 of 31 March 1992 superseded by 2001/83) expressly recognise the possibility of establishing mechanisms for the voluntary control of advertising on the part of self-regulation organisms, as well as the appeal to such organisms, regardless of ordinary judicial or administrative procedures. Self-regulation systems are, therefore, the voluntary response of the industry to society's demand for trust and credibility guarantees in advertising.
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- Directive 2001/83/CE of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
- Spanish Constitution 1978.
- Law 14/1986 of 25th of April, General Health.
- Law 34/1988 of 11th of November, General Publicity.
- Law 3/1991 of 10th of January on Unfair Competition.
- Royal Decree 1416/1994 of 25th June, regulating the Publicity of Medicines for Human Use.
- Organic Law 3/2018 of 5th of December 2018, on Personal Data Protection and Digital Rights Guarantee.
- Law 44/2003 of 21st of November on Healthcare Professions Arrangements.
- Legislative Royal Decree 1/20015, July 24th, approving consolidated version of the Law 29/2006 of 26th of July on Guarantees and the Rational Use of Medicines and Healthcare Products.
- Legislative Royal Decree 1/2007 of 16th November, approving the revised text of the General Law for the Defense of Consumers and Users and Other Complementary Laws.
- REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
- Order SAS/3470/2009 of 16th of December, publishing the Guidelines on Post-Authorisation Observation Studies of Medicines for Human Use.
- Circular 6/95 of 25th of April of the General Direction of Pharmacy and Healthcare Products, clarifications to the Royal Decree 1416/1994 of 25 June, regulating the Publicity of Medicines for Human Use.
- Circular 7/99 of 27th of May of the General Direction of Pharmacy and Healthcare Products, modification of Section II Item 7 of the Circular 6/95 on clarifications of the Royal Decree 1416/1994 of 25 June regulating the Publicity of Medicines for Human Use.
- Organic Law 5/2010 of 22nd of June, which modified Organic Law 10/1995 of 23rd November, on the Criminal Code.
- Organic Law 1/2015 of 30th of March, which modified Organic Law 10/1995, of 23rd November, on the Criminal Code.
- Royal Decree 1090/2015, of 4 December 2015, governing clinical trials with medicines, ethical committees for medicines research, and the Spanish Clinical Studies Registry.
- Royal Decree 1302/2018, of 22 October 2018, amending Royal Decree 954/2015, of 23 October 2015, governing the indication, use and dispense authorization of medicines and medical devices for human use, by the nursing profession.
- Guide on the publicity of medicines for human use, April 2016.
- Circular 1/2000 of 10 May of the General Direction of Health of the Community of Madrid, General Rules in Application of Certain Articles of the Royal Decree 1416/1994 of 25 June (Regulating the Publicity of Medicines for Human Use), regarding the Publicity Aimed at those Authorised to Prescribe or Dispense Medicines.
- Circular 1/2002 of 25 November of the General Direction of Pharmacy and Healthcare Products of the Health Ministry of the Community of Madrid regarding Arrangements of the Medical Visit and Other Activities of Promotion of Medicines within the Sole Public Usage Healthcare Network of the Community of Madrid.
- Supreme Court Judgement of 25 June 2008, declaring Void Certain Sections of Circular 1/2002.
- Resolution of 15 January 2010 of the General Direction of Arrangements and Inspection of the Healthcare Ministry of the Community of Madrid, authorising the Telematic Registry of the Healthcare Ministry to the Execution of Telematic Procedures during the Process of Records of Several Administrative Proceedings.
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